COURSE: Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03129659

Collaborator

(none)

230

Enrollment

Locations

Arm

Anticipated Duration (Months)

115

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is greatly dictated by the results of high-sensitivity troponins. In a substantial number of patients this approach does not provide a conclusive work-up. Patients typically present with slightly elevated high-sensitivity troponins without significant changes during serial sampling and no other clinical clues that can aid in determining the etiology of their chest pain complaints. Uncertainty remains about the optimal diagnostic management of these patients and they are often admitted to undergo invasive angiography. Coronary CT angiography can improve efficiency of clinical care in these patients by reducing unnecessary hospital admissions and invasive angiography. In this study, the investigators will investigate whether a diagnostic strategy comprising of early coronary CT angiography is more clinically efficient than standard optimal care in patients with an inconclusive work-up for non-ST-elevation acute coronary syndrome.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Chest Pain	Diagnostic Test: Coronary CT Angiography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-group Coronary CT angiography	Diagnostic Test: Coronary CT Angiography Coronary CT angiography

Arm

Intervention/Treatment

Experimental: CT-group

Coronary CT angiography

Diagnostic Test: Coronary CT Angiography

Coronary CT angiography

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS. [30 day]
Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.

Secondary Outcome Measures

Potential improvement of diagnostic accuracy with FFR-CT. [30 day]
Off-line calculation of FFR-CT will be performed and the diagnostic accuracy for NSTE-ACS will be determined and compared to conventional coronary CT angiography.
Clinical characteristics of no obstructive coronary artery disease on CT. [30 day]
To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients presenting to the emergency department with symptoms suggestive of NSTE-ACS. They do not fulfil criteria for either "rule-in" or "rule-out" NSTE-ACS based on serial sampling of high-sensitivity troponins and standard clinical work-up.

Exclusion Criteria:

Inability or unwillingness to provide informed consent.
History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery.
Previous examination with either invasive angiography or CCTA in the last 3 years.
Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain.
CCTA-specific contra-indications:
Allergy to iodine contrast media
Pregnancy
Impaired renal function: estimated glomerular filtering rate <60% of the age-corrected normal values
Severe arrhythmia likely to affect image interpretation
BMI > 40
Inability to cooperate during the examination.